[Translation] A Phase I/II study evaluating the safety, tolerability, and pharmacokinetics of the PSMA-targeted fluorescent contrast agent DGPR1008 for intraoperative imaging of prostate cancer
Ⅰ期阶段:
主要研究目的:
评估DGPR1008在健康受试者中单次给药的安全性、耐受性和药代动力学特征。
次要研究目的: 根据安全性和药代动力学结果评估DGPR1008的最大耐受剂量(MTD)和临床Ⅱ期推荐剂量(RP2D)。
Ⅱ期阶段:
主要研究目的:
评估DGPR1008在患者中单次给药的安全性和药代动力学特征。
次要研究目的:
评估DGPR1008联合近红外荧光成像设备检测在患者手术中的成像的有效性。
[Translation] Phase I stage:
Main study objectives:
To evaluate the safety, tolerability and pharmacokinetic characteristics of a single dose of DGPR1008 in healthy subjects.
Secondary study objectives: To evaluate the maximum tolerated dose (MTD) and clinical phase II recommended dose (RP2D) of DGPR1008 based on safety and pharmacokinetic results.
Phase II stage:
Main study objectives:
To evaluate the safety and pharmacokinetic characteristics of a single dose of DGPR1008 in patients.
Secondary study objectives:
To evaluate the effectiveness of imaging in patients during surgery using DGPR1008 combined with near-infrared fluorescence imaging equipment.